Subject to any further order, order 2 is stayed for 21 days and, if a notice of appeal isfiled within that time, until the determination of the appeal.

Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011

IN THE FEDERAL COURT

OF AUSTRALIA

NEW SOUTH WALES

DISTRICT REGISTRY

GENERAL DIVISION

NSD

643 of 2010

BETWEEN:

CANCER

VOICES AUSTRALIA

First Applicant

YVONNE D'ARCY

Second Applicant

AND:

MYRIAD

GENETICS INC

First Respondent

GENETIC TECHNOLOGIES LIMITED

(ABN 17 009 212 328)

Second Respondent

JUDGE:

NICHOLAS J

DATE:

15 FEBRUARY 2013

PLACE:

SYDNEY

REASONS FOR JUDGMENT

GENERAL BACKGROUND

1

The issue that arises in this case is of considerable importance. It relates to the patentabilityof genes, or gene sequences, and the practice of “gene patenting”. Briefly stated, the issue tobe decided is whether under thePatents Act 1990

(Cth) (theAct), a valid patent may begranted for a claim that covers naturally occurring nucleic acid–

either deoxyribonucleic acid(DNA) or ribonucleic acid (RNA)–

that has been “isolated”. In this context, the word“isolated” implies that naturally occurring nucleic acid found in the cells of the human body,whether it be DNA or RNA, has been removed from the cellular environment in which itnaturally exists and separated from other cellular components also found there.

2

The genes found in the human body are made of nucleic acid. The particular gene withwhich the patent in suit is concerned (BRCA1) is a human breast and ovarian cancerdisposing gene. Various mutations that may be present in this gene have been linked tovarious forms of cancer including breast

cancer and ovarian cancer.

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2

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3

Whether or not a valid patent may be granted for a claim to naturally occurring “isolated”nucleic acid depends on whether such a substance is “a manner of manufacture” within themeaning of s

6 of the Statute of Monopolies: see s

18(1)(a) of the Act. This question must inturn be answered in accordance with the principles enunciated by the High Court inNationalResearch Development Corporation v Commissioner of Patents

(1959) 102

CLR

252(NRDC) and other relevant authorities.

4

The patent in suit is Australian standard patent number 686004 (the Patent). The prioritydate of the Patent is 12 August 1994. The first respondent is the current owner of the Patent.The Patent includes 30 different claims but it is only the validity

of claims 1-3 that is in issue.

5

The applicants contend that claims 1-3 of the Patent are invalid on the basis that none claim amanner of manufacture and, therefore, do not satisfy the requirements of s 18(1)(a) of theAct. The applicants claim declarations to that effect, and orders revoking claims 1-3 of thePatent. The standing of the applicants to seek such relief is not in issue.

18(1)(a) of the Act because each claim comprises “isolated” nucleic acid that is notmaterially different to nucleic acid that occurs in nature. In particular, they rely on evidencesaid to show that there is no significant or material difference between nucleic acid in theirnatural and isolated states. According to the applicants, naturally occurring DNA and RNA,even in isolated form, are products of nature that cannot form the basis of a valid patent.

7

The respondents contend that each of the disputed claims is valid because it claims a productthat consists of an artificial state of affairs, providing a new and useful effect that is ofeconomic significance. This is all that is required, according to the respondents, to establishthe existence of subject matter that satisfies the requirements of s

18(1)(a) of the Act asinterpreted in light of theNRDC

case. The respondents rely on evidence said to show thatnucleic acid found in a human cell differs chemically, structurally and functionally from theisolated nucleic acidof the disputed claims.

8

There are a number of preliminary observations to make concerning the issues in thisproceeding:



It is common ground that the disputed claims are invalid if they encompass anyisolated nucleic acid that does not constitute patentable subject matter. This isbecause the validity of the disputed claims must be assessed across their full breadth.

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3

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Thus, the fact that the disputed claims extend to forms of nucleic acid that have beensynthesized in the laboratory (cDNA) will not save them if, as the applicants contend,they also extend to forms of nucleic acid that are not patentable.



The case was for the most part conducted on the basis that all of the disputed claimswill stand or fall together, and that if claim 1 is invalid because it includes non-patentable subject matter, claims 2 and 3 will also be invalid for the same reason.However, while claim 1 is directed to “isolated nucleic acid” encompassing bothDNA and RNA, claims 2 and 3, which are dependent on claim 1, are limited to“isolated nucleic acid ... which is a DNA”.



The applicants challenge the disputed claims solely on the basis that they include non-patentable subject matter. No other ground of invalidity (including lack of novelty,lack of inventive step, lack of utility

or lack of fair basis) is relied upon by theapplicants. In particular, it may be assumed that the inventors were the first to isolatethe nucleic acids referred to in the disputed claims.



The applicants accepted that the subject matter of each of the disputed claims satisfiedthe second of the essential qualities of an invention referred to by the High Court inNRDC. In this regard, the applicants accepted that the subject matter of the disputedclaims was of “economic significance”.



Although the applicants initially sought to rely upon s

18(2) of the Act, theyultimately abandoned any argument based upon it. Even so, s

18(2) of the Act is stillrelevant to the issues in the case and it will be necessary to say more about it later inthese reasons.

SCIENTIFIC BACKGROUND

Expert Witnesses

9

There was expert evidence given by three eminent experts. Dr Suthers (called by theapplicants) and Professor Brown (called by the respondents) were both cross-examined.Professor Rasko (also called by the respondents) was not cross-examined. I found Dr Suthersand Professor Brown to be impressive witnesses. Although I did not have the opportunity tosee Professor Rasko in the witness box (because he was not required for cross-examination), Ifound his affidavit extremely helpful. All three witnesses gave evidence that providedimportant background to the field of the invention. Unless otherwise indicated, the

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4

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statements appearing in this section of these reasons comprise findings based upon expertevidence thatwas not in dispute.

The eukaryotic cell

10

The human body is a multi-cellular eukaryotic organism which consists of a large number ofdifferent types of eukaryotic cells. Eukaryotic cells are cells which contain a membrane-bound nucleus. These cells communicate and co-operate with each other for the commongood of the organism. The process by which cells reproduce is known as “cell division”.This process is binary in the sense that each cell is able to separate into two daughter cells.

11

The human body can

sense when high rates of cell division are necessary. For example, if aparticular area of the body receives a severe cut with blood loss, the body can respond byproducing a number of new blood cells to replace the cells that were lost. When the cut is

healing, the body is able to decrease the production of blood cells to prevent over-supply.However, cells may sometimes divide in an abnormal or uncontrolled manner. The abnormalor uncontrolled division of cells is referred to as cancer.

The components of a human cell

12

Cells found in the human body consist of three main parts: the nucleus, the cytoplasm and thecell membrane. The cell membrane defines the outer boundary of the cell and separates itscontents from the environment in which it exists. The nucleus of the cell appears as a cellwithin a cell. The boundary of the nucleus is defined by a nuclear envelope or membrane.

13

The cytoplasm comprises everything between the cell membrane and the nucleus. Themajority of the cytoplasm is a liquid called cytosol which consists of water, salts and organicmolecules. However, the cytoplasm also contains a number of components (includingribosomes) that have specific functions involving, amongst other things, protein and energyproduction.

14

The nuclear envelope separating the nucleus from the cytoplasm incorporates pores throughwhich molecules may move between the nucleus and the cytoplasm.

15

DNA and RNA are molecules found within the nucleus of cells within the human body.DNA contains the genetic information that directs the growth, development, maintenance andreproduction of the human body. As I will explain, this information is made available forthese purposes via RNA.

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5

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The chemical structure of DNA

16

Native DNA (genomic DNA) is an extremely long three-dimensional molecule consisting ofa number of repeating monomeric units called nucleotides. These are linked end to end toform a strand (chain) of nucleotides (a polynucleotide chain). Each nucleotide is comprisedof three separate chemical groups: a

nitrogen-containing (nitrogenous) base, a phosphategroup and a five-carbon sugar group comprising deoxyribose.

17

In DNA, nucleotides are linked to one another by covalent bonds running from the 5th

carbon(5’) of the sugar group of one nucleotide to the third carbon (3’) of the phosphate group of theadjacent nucleotide. These bonds are referred to as phosphodiester bonds. They form the“sugar-phosphate backbone” of the DNA from which the bases protrude.

18

DNA chains have two distinctive ends. One end of the chain has a free 5’ on the sugar group,and the other end has a free 3’ on the phosphate group. By convention, DNA chains areusually depicted from left to right commencing at the free 5’ of the sugar group and ending atthe free 3’ of the phosphate group.

19

There are four types of nitrogenous bases found in DNA. These nitrogenous bases (usuallyreferred to by their initial letter) are adenine (A), guanine (G), cytosine (C) and thymine (T).

20

DNA chains contain repeating sugar-phosphate groups that are always linked together byphosphodiester bonds. However, the four bases of DNA (A, G, C, T) can be attached in anyorder along the sugar-phosphate backbone. The bases are covalently bonded to the sugargroup.

21

In the cell nucleus, DNA almost always exists as a double helix formed by the intertwining oftwo polynucleotide chains. The two strands wind around each other to form the double helix.The sugar-phosphate backbone forms the outside of the double helix. The bases lie on theinside, in pairs, perpendicular to the axis of the double helix. They are paired along thelength of the double helix and joined together by hydrogen bonds.

22

In DNA, G bonds with C, and A bonds with T. The pairingof G to C and A to T is referredto as base pairing.

Base pairs can only form if two DNA strands are orientated in theopposite direction (anti-parallel) so that one strand runs in the 5’ to 3’ direction and the otherin the 3’ to 5’ direction. The strand running in the 5’ to 3’ direction is often referred to as the“sense” or “coding” strand as opposed to the “anti-sense” or “non-coding” strand which runsin the 3’ to 5’ direction.

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6

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23

In DNA, if the sequence of one polynucleotide chain is known (eg ATCGG on

the 5’ to 3’strand), then that of the other polynucleotide chain (ie TAGCC on the 3’ to 5’ strand) may beinferred. These matching sequences are referred to as complementary sequences orcomplementary strands.

Nucleosomes, chromatin fibres andchromosomes

24

DNA is compacted in the nucleus in two main ways. First, the DNA double helix wrapsaround spooling proteins known as histones by way of hydrogen bonding to form complexesknow as nucleosomes. Each nucleosome consists of a protein core around

which doublestranded DNA is wound. Second, nucleosomes are stacked on top of each other to formchromatin fibres which are organised into chromosomes.

25

In humans, the DNA in the nucleus is divided between two sets of chromosomes. There are24 differentchromosomes comprising 22 homologous chromosomes and two sexchromosomes. By convention, the homologous chromosomes are numbered from the largest(1) to the smallest (22), while the sex chromosomes are designated X and Y.

RNA is much shorter in length than DNA. RNA is also single-stranded. Because of this, thenitrogenous bases of RNA are exposed which allows short stretches of these bases to formbase pairs with other bases on the same strand resulting in folding of the molecule. RNAoften takes the shape of a highly folded molecule.

28

There are a number of different species of RNA which perform a variety of biologicalfunctions. Those that are most relevant for present purposes are known as messenger RNA(mRNA) and pre-messenger RNA (pre-mRNA). Also relevant is RNA polymerase(RNApol), an enzyme that (in association with promoters and terminators in DNA),determine where transcription of a gene should start and finish.

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7

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The human genome

29

A gene is a functional unit of contiguous DNA which encodes a particular protein. Itprovides the chemical blueprint used by other parts of the cell to produce protein. When agene is “expressed” it will often result in the synthesis of a protein by other parts of cell.

30

Human genes generally comprise sequences of DNA that specifically code for a particularprotein, interspersed with sequences of DNA that do not code for a particular protein.Sequences of DNA coding for a particular protein are thought to account for approximately1% of the human genome.

31

The sequences of DNA that comprise a geneare referred to as exons or exonic sequences.Most exonic sequences will code for a particular protein, but they also include otherregulatory or non-coding regions that, although not coding for a particular protein, areimportant to the translation of mRNA. These non-coding sequences are referred to asuntranslated regions (UTR) and occur at the 5’ end (5’ UTR) and 3’ end (3’ UTR) of thegene. Other sequences that do not code for protein, and which do not form part of the UTRof the gene, are referred to as introns or intronic sequences. Introns are found in DNA andpre-mRNA, but not in mRNA, which includes only the exonic sequences found in the DNAfrom which it is copied. Introns account for about 25% of the human genome. Theremainder is made up of

repetitive and other intergenic DNA.

32

The term “genome” refers to the entirety of the DNA sequence within an organism which, ina human, comprises approximately 3.2 billion individual nucleotides. The human genomecomprises approximately 25,000 genes arranged onto chromosomes. In the absence ofmutation, all nucleated cells in the human body contain the same genomic DNA sequences.

Proteins, polypeptides and amino acids

33

A protein is a polypeptide or a number of polypeptides consisting of a sequence of aminoacids linked together by peptide bonds on a phosphate backbone.

Amino acids act as thebuilding blocks of proteins and each type of protein has its own unique amino acid sequence.There are 20 different amino acids known in nature and they are as follows:

Proteins come in an immense variety of different shapes and sizes, and perform manydifferent and complex functions. For example, some proteins act as enzymes, others generatemovement, and others act to form structures (histones) used to pack DNA or complexes(ribosomes) that synthesise more proteins. There are also proteins that regulate cell division.When the DNA that encodes these regulatory proteins is mutated or damaged, abnormal oruncontrolled cell division may result.

The genetic code

35

The genetic code consists of groups of three nucleotides, each of which represents one aminoacid. These nucleotide groups are referred to as codons or triplets. The grouping of fourpossible nucleotides in DNA (A,G,C,T) and RNA (A,G,C,U) into different codonspermits 64possible combinations of nucleotides.

36

There are a number of codons that code for the same amino acid (eg. phenylalanine (Phe)-

TTT, TTC, glutamine (Gln)-

CAA, CAG). Indeed, most amino acids have multiple codons,which means that there are a number of different DNA or RNA sequences that can code forthe same protein.

37

The codon ATG in DNA (AUG in RNA) codes for methionine (Met), but will frequently actas a “start” signal. A fixed point in a nucleotide sequence designated by a start codon

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9

-

establishes the groups (the reading frame) in which codons are translated. There are also anumber of codons (in DNA, TAA, TAG and TGA, in RNA, UAA, UAG and UGA) that donot code for amino acids, but instead act as “stop” signals that terminate the process oftranslation.

38

The genetic code is usually presented in the form of a table of nucleotides. If the first, secondand third bases in a codon are known, then the table can be used to predict the specific aminoacid encoded by that codon. The table below is such an example:

I shall illustrate how this table works with just a few examples. If one wants to know whatsequences of bases codes for Glutamine (Glu) one can see from the table that there are twocodons that do so: GAA and GAG. In the case of Serine

(Ser) one can see that there are 6different codons that code for this amino-acid: UCU, UCC, UCA, UCG, AGU and AGC. Asin the above table, the generic code is typically depicted as a table of RNA nucleotides. Thistable may be used to interpret DNA sequences by substituting T where U appears in the table.

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10

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39

Genetic information in DNA in the form of sequences of codons that represent specific aminoacid sequences ultimately determines what particular protein will be synthesised in the cell.

The process

of gene expression

40

The process by which a cell produces protein is referred to as “gene expression”. Theproduction of pre-mRNA is the first step in the process of gene expression. This is followedby the production of mRNA. RNA plays a central role in

gene expression through itsinvolvement in the processes of “transcription” and “translation”.

Transcription

41

Transcription is a process that takes place within the nucleus of the cell whereby a portion ofthe DNA nucleotide sequence of a gene is copied into an RNA nucleotide sequence. Throughthis process, a single strand of the DNA double helix is used as a template (or, as it issometimes called, the “sense” or “non-coding” strand) to synthesise a complementary strandof nascent mRNA known as pre-mRNA. Pre-mRNA includes both the exonic and intronicsequences of the gene transcribed from the DNA. The sequenceof the nucleotide chain ofthe pre-mRNA strand is determined by base pairing with the DNA template (the “anti-sense”or “non-coding”) strand. Consequently, the nucleotide sequence of the strand of pre-mRNAtranscribed from the DNA template stand will correspond to the non-template (the “sense” or“coding”) DNA strand.

42

During transcription, a chemical modification is made at the 5’ end of the transcribedsequence which results in the addition of a “cap”. The cap protects the molecule fromenzymatic degradation and assists in the transport of the mature mRNA molecule to thecytoplasm. A further modification is made to the 3’ end of the sequence by the addition of astring of adenosine bases referred to as a poly-A tail.

43

Once the cap and poly-A tail have been added to the ends of the pre-RNA sequence theintrons are removed and the exons joined together by a process known as RNA splicing.Splicing is a process performed by an enzyme complex referred to as the spliceosome.

Thepre-RNA transcript of exons and introns can be spliced to produce different polynucleotidesequences by a process referred to as alternative splicing.

44

Once splicing has occurred, the resulting mRNA molecule will consist of a complementarysequence of exons found in the DNA strand from which they were transcribed with a cap atthe 5’ end and a poly-A tail at the 3’ end.

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Translation

45

Once the process of transcription is complete, the mRNA molecule is transported throughnuclear pores within the nuclear envelope into the cytoplasm where it is available fortranslation. Translation is a complex process by which the nucleotide sequence of an mRNAmolecule is used as a template for the manufacture of the polypeptide chains which takesplace in ribosomes located in the cytoplasm. For present purposes, it is sufficient to note thatthe ribosome manufactures the polypeptide chains in accordance with the mRNA template.

ISOLATION OF DNA AND

RNA

46

As previously explained, an isolated DNA sequence is a sequence of

DNA that has beenremoved from its normal cellular environment. Professor Rasko gave a detailed explanationof how DNA may be removed from its normal cellular environment. The following summaryis drawn from his evidence.

47

Typically, DNA is obtained from

cells removed from a sample of tissue or blood extractedfrom an individual. The tissue sample is broken down into clumps of cells or individual cellsusing enzymes or chemicals suitable for that purpose. In the case of a blood sample, the cellsare already separated.

48

The bursting of the cell membrane or the nucleus membrane is referred to as cell lysis andcan be achieved through techniques known as sonication (which involves the application ofultrasonic pressure waves) or grinding (which involves theapplication of physical disruptiveforces). In this way the contents of the nucleus, including the DNA and RNA, can bereleased into a free-floating liquid suspension. Cell lysis results in the entire genomic DNAbeing released from the nucleus of the cell.

49

Proteins associated with DNA (including histones) are then degraded by the addition ofenzymes known as proteases. This results in the destruction of the nucleosomes but does noteliminate all of the protein associated with the DNA.

50

A high salt solution is then added to precipitate the degraded proteins including those whichare still closely associated with the DNA. The degraded proteins are then separated from theDNA using a well known chemical procedure that takes advantage of the fact that proteinsare soluble in phenol, and DNA and RNA are not soluble in phenol (but are soluble inchloroform).

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12

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51

After centrifugation, the DNA and RNA are located in the interface between the phenol andthe chloroform. Enzymes may then be applied in order to break down the RNA, leaving onlypurified DNA. The DNA can be precipitated from its soluble state into a solid state by theaddition of ethanol or isopropanol. Further centrifugation results in a pellet of DNA.

52

Professor Rasko identified a number of techniques that may be used to create synthetichuman DNA. For present purposes, that which is most relevant is a technique for template-based DNA synthesis that involves the use of mRNA as a template to create complementaryDNA (cDNA). This technique is called “reverse transcription” because it involves the use ofa particular enzyme (not naturally found in humans) known as reverse transcriptase.

53

The reverse transcription technique takes advantage of the existence of the poly-A tail onmRNA, allowing the mRNA tobe isolated for use as a template for DNA synthesis. Theresult of the reverse transcription technique is to create an RNA-cDNA hybrid molecule thatcan then be converted to a double stranded DNA molecule using several different approaches.These hybridmolecules are better suited than mRNA molecules for use in molecular biologyapplications because mRNA is less stable than DNA. Nevertheless, it is clear that, like DNA,mRNA can also be isolated from the natural environment of the cell.

54

Dr Suthers explained that once a DNA sample has been isolated, the DNA sequence can bemapped using a variety of methods. Genetic testing is then completed by comparing therelevant DNA sequence of the sample to a normal reference sequence. The latter may be oneof many reference sequences developed under the auspices of professional bodies orgovernment agencies in the US or Europe. Of course, the goal of genetic testing is todetermine what variations, if any, are present in a specific region of DNA and what theirclinical significance is.

THE PATENT

The field of the invention

55

The title of the Patent is “In vivo mutations and polymorphisms in the 17q-linked breast andovarian cancer susceptibility gene”. The reference to “17q” in the title indicates that BRCA1,the

relevant gene, is found on the long arm of chromosome 17. This part of chromosome 17is estimated to consist of about 8 million base pairs.

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56

According to the Patent, the BRCA1 gene is composed of 23 coding exons arrayed on morethan 100,000 base pairs (100 kb) in genomic DNA. The field of the invention is described inthe Patent in these terms:

The present invention relates generally to the field of human genetics. Specifically,the present invention relates to methods and materials used to isolate anddetect ahuman breast and ovarian cancer predisposing gene (BRCA1), some mutant alleles ofwhich cause susceptibility to

cancer, in particular, breast and ovarian cancer. Morespecifically, the invention relates to germline mutations in the BRCA1 gene andtheiruse in the diagnosis of predisposition to breast and ovarian cancer. The presentinvention further relates to somatic mutations in the BRCA1 gene in human breastand ovarian cancer and their use in the diagnosis and prognosis of human breast andovarian cancer. Additionally, the invention relates to somatic mutations in theBRCA1 gene in other human cancers and their use in the diagnosis and prognosis ofhuman cancers. The invention also relates to the therapy of human cancers whichhave a mutation in

the BRCA1 gene, including gene therapy, protein replacementtherapy and protein mimetics. The invention further relates to the screening of drugsfor cancer therapy. Finally, the invention relates to the screening of the BRCA1 genefor mutations, which are useful for diagnosing the predisposition to breast andovarian cancer.

Background to the invention

57

The Patent states that breast cancer is one of the most significant diseases that affects

women.According to the Patent, mutation of the BRCA1 gene is thought to account forapproximately 45% of familial (hereditary) breast cancer, and at least 80% of familial cancerinvolving both breast and ovarian cancer.

The invention

58

The Patent states

that “[t]he present invention relates generally to the field of humangenetics”. The Patent includes a “summary of the invention” which is in identical terms tothe description of the field of invention reproduced at para [56] above. The Patent alsoincludes a “detailed description of the invention”. The detailed description includes thefollowing statement:

The present invention provides an isolated polynucleotide comprising all, or a portionof the BRCA1 locus or of a mutated BRCA1 locus, preferablyat least eight bases andnot more than about 100 kb in length.

Such polynucleotides may be antisensepolynucleotides. The present invention also provides a recombinant constructcomprising such an isolated polynucleotide, for example, a recombinant constructsuitable for expression in a transformed host cell.

59

The Patent elsewhere also explains that “[t]he “polynucleotide compositions of thisinvention” may include RNA, DNA and cDNA. The Patent states:

The polynucleotide compositions of this invention include RNA, cDNA, genomic

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DNA, synthetic forms, and mixed polymers, both sense and antisense strands, andmay be chemically or biochemically modified or may contain non-natural orderivatized nucleotide bases, as will be readily appreciated by those skilled

in the art.

60

The Patent also includes additional statements indicating that the invention provides detectionmethods, isolated antibodies and screening methods that may be useful for identifyingmutations for diagnostic and therapeutic purposes.

61

The Patent explains that it is a discovery of the invention that:

… the BRCA1 locus which predisposes individuals to breast cancer and ovariancancer, is a gene encoding a BRCA1 protein, which has been found to have nosignificant homology with known protein or DNA sequences. This gene is termedBRCA1 herein. It is a discovery of the present invention that mutations in theBRCA1 locus in the germline are indicative of a predisposition to breast cancer andovarian cancer. Finally, it is a discovery of the present invention that somaticmutations in the BRCA1 locus are also associated with breast cancer, ovarian cancerand other cancers, which represents an indicator of these cancers or of the prognosisof these cancers. The mutational events of the BRCA1 locus can involve deletions,insertions and point mutations within the coding sequence and the non-codingsequence.

Starting from a region on the long arm of human chromosome 17 of the humangenome, 17q, which has a size estimated at about 8 million base pairs, a region whichcontains a genetic locus, BRCA1, which causes susceptibility to cancer, includingbreast and ovarian cancer, has been identified.

The region containing the BRCA1 locus was identified using a variety of genetictechniques. Genetic mapping techniques initially defined the BRCA1 region in termsof recombination with genetic markers. Based upon studies of large extendedfamilies (“kindreds”) with multiple cases of breast cancer (and ovarian cancer casesin some kindreds), a chromosomal region has beenpinpointed that contains theBRCA1 gene as well as other putative susceptibility alleles in the BRCA1 locus …

Definitions

62

The various passages from the Patent to which I have referred use a number of defined terms.The following definitions are of particular relevance:

“Encode”. A polynucleotide is said to “encode” a polypeptide if, in its native stateor when manipulated by methods well known to those skilled in the art, it can betranscribed and/or translated to produce the mRNA for and/or the polypeptide or afragment thereof. The anti-sense strand is the complement of such a nucleic acid, andthe encoding sequence can be deduced therefrom.

“Isolated” or “substantially pure”. An “isolated” or “substantially pure” nucleicacid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separatedfrom other cellular components which naturally accompany a native human sequenceor protein, e.g., ribosomes, polymerases, many other human genome sequences andproteins. The term embraces a nucleic acidsequence or protein which has beenremoved from its naturally occurring environment, and includes recombinant orcloned DNA isolates and chemically synthesized analogs or analogs biologicallysynthesized by heterologous systems.

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“BRCA1 Allele” refers to normal alleles of the BRCA1 locus as well as allelescarrying variations that predispose individuals to develop cancer of many sitesincluding, for example, breast, ovarian, colorectal and prostate cancer. Suchpredisposing alleles are also called “BRCA1 susceptibility alleles”.

“BRCA1 Locus,” “BRCA1 Gene,” “BRCA1 Nucleic Acids” or “BRCA1Polynucleotide” each refer to polynucleotides, all of which are in the BRCA1 region,that are likely to be expressed in normal tissue, certain alleles of which predispose an

individual to develop breast, ovarian, colorectal and prostate cancers. Mutations atthe BRCA1 locus may be involved in the initiation and/or progression of other typesof tumors. The locus is indicated in part by mutations that predispose individuals todevelop cancer. These mutations fall within the BRCA1 region describedinfra. TheBRCA1 locus is intended to include coding sequences, intervening sequences andregulatory elements controlling transcription and/or translation. The BRCA1 locus isintended to include all allelic variations of the DNA sequence.

These terms, when applied to a nucleic acid, refer to a nucleic acid which encodes aBRCA1 polypeptide, fragment, homolog or variant, including, e.g., protein fusions ordeletions. The nucleic acids ofthe present invention will possess a sequence which iseither derived from, or substantially similar to a natural BRCA1-encoding gene orone having substantial homology with a natural BRCA1-encoding gene or a portionthereof. The coding sequence for a BRCA1 polypeptide is shown in SEQ ID NO:1,with the amino acid sequence shown in SEQ ID NO:2.

The Patent also states that the term “BRCA1 polypeptide” refers to the protein or polypeptideencoded by the BRCA1 locus, variants or fragments thereof.

63

The terms “mutations” and “polymorphisms” as used in the Patent are not defined. However,a mutation is a variation in a gene that is not found in the same gene in its typical and mostcommon (wild-type) form. Mutations may be disease-causing or they may be benign.

Apolymorphism is also a variation in a gene. According to Dr Suthers, polymorphisms do notcause disease and are not clinically relevant. They are found in the DNA of a largeproportion of the population. While nothing turns on the point, the term polymorphismseems to be used somewhat differently in the Patent.

The SEQ ID No.1: the “wild type” sequence

64

SEQ ID No.1 is a sequence listing for the BRCA1 wild-type gene. It consists of 5,914 basepairs and represents the coding sequence of a nucleicacid (cDNA) which encodes theBRCA1 polypeptide. Since SEQ ID No.1 is a cDNA sequence, it contains only the exonicsequences including the non-coding sequences that appear at the beginning and end of thesequence.

65

SEQ ID No.1, as reproduced in the Patent, shows nucleotides and codons, both of which arenumbered sequentially. The particular amino acid encoded by each of the codons in thenumbered sequence is also shown. The coding sequences start with ATG (the “start” signal,

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codon number 1) and terminate with TGA (a stop signal, codon number 1864). To moreclearly illustrate how SEQ ID No.1 is presented I shall set out the first 263 nucleotidesshown:

66

The first 119 nucleotides do not code for a polypeptide but nevertheless form part of theexonic sequences. Codon number 1 (ATG), the first of the separately number codons, codesfor methionine (Met) which in this sequence acts as the start signal. The coding sequenceshown in SEQ ID No.1 ends at codon 1864 (TGA) which acts as a stop signal, which is thenfollowed by about three lines of additional non-coding nucleotides.

67

Because SEQ ID No.1 is a coding sequence for cDNA, the bases making up the sequenceinclude T (found in DNA) but not U as found in a RNA sequence. However, a person skilledin the art would know that the corresponding RNA sequence may be obtained by substitutingU for T where the latter appears in SEQ ID No.1.

The Tables

68

There are tables set out in the Patent that identify mutations or polymorphisms by referenceto the sequence listing in SEQ ID No.1. In particular:



Tables 12, 12A and 14 identify “predisposing mutations” found in the BRCA1 geneof various patients. These mutations are recorded as variations in coding sequences asshown in SEQ ID No.1. Here is an example drawn fromTable 12:

Patient

Codon

Nucleotide

Change

Amino AcidChange

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17

-

BT098

1541

GAGTAG

GluStop

SEQ ID No.1 shows that codon numbered 1541 is normally GAG, not TAG as foundin the BRCA1 gene of this patient.



Table 18 identifies what are referred to as“Polymorphisms in BRCA1 Genomic DNAExons”. Information included in this table is presented in much the same style as inTables 12, 12A and 14.



Table 19 identifies what are referred to as “Polymorphisms in BRCA1 Genomic DNAIntrons”. However, since the polymorphisms identified in Table 19 occur in intronicsequences, it is not possible to relate them to SEQ ID No.1 which, as previouslymentioned,

only includes the exonic sequences of the BRCA1 gene. For this reason,the parties agreed that the reference to Table 19 in each of the disputed claims was anerror and should be disregarded.

The disputed claims

69

The disputed claims are in the following terms:

1.

An isolated nucleic acid coding for a mutant or polymorphic BRCA1polypeptide, said nucleic acid containing in comparison to the BRCA1polypeptide encoding sequence set forth in SEQ.ID No:l one or moremutations or polymorphisms selected from themutations set forth in Tables12, 12A and 14 and the polymorphisms set forth in Tables 18 and 19.

2.

An isolated nucleic acid as claimed in claim 1

which is a DNA coding for amutant BRCA1

polypeptide, said DNA containing in comparison to theBRCA1

polypeptide encoding sequence set forth in SEQ.ID No:1

one ormore mutations set forth in

Tables 12, 12A and 14.

3.

An isolated nucleic acid as claimed in claim1

which is a DNA coding for apolymorphic BRCA1 polypeptide, said DNA containing in comparison to theBRCA1

polypeptide encoding sequence set forth in SEQ.ID No:1

one ormore polymorphisms set forth in Tables 18 and 19.

70

Claim 1 extends to isolated DNA, RNA and cDNA that has a BRCA1 polypeptide encodingsequence as shown in SEQ ID No.1 with one or more of the mutations or polymorphismsspecified in the relevant tables. By contrast, dependent claims 2 and 3 extend only to DNAcontaining one or more such sequences. Claims 2 and 3 both refer to an isolated nucleic acidas claimed in claim 1 “which is a DNA coding for” one or more of the identified mutations(in claim 2) or polymorphisms (in claim 3). Here, the reference to “a DNA coding” is areference to the relevant DNA sequence that encodes for a relevant mutant or polymorphicpolypeptide.

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18

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71

The word “coding” (as in “coding” for a mutant or polymorphic polypeptide) is not definedin the Patent. However, the word “encode” (as in an “encoding sequence”) is defined byreference to the ability of a polynucleotide (ie. a chain of nucleotides) in its natural state, orwhen manipulated by well known methods, to “encode” a polypeptide. A polynucleotide that“codes”

for or “encodes” a polypeptide is one that exhibits the sequence of bases that can, inthe natural environment of a cell, result in the expression of such a polypeptide. In thisregard, I do not understand there to be any difference in meaning between the words “coding”and “encoding” in the present context. Encoding sequences are those that code forpolypeptides either in the natural environment of the cell or when manipulated by well knownmethods.

72

Each of the disputed claims is to a chemical composition. That is to say, they claimsubstances that are defined by the presence of particular atoms that are arranged in particularways. However, the disputed claims do not say anything about the length of thepolynucleotide chains with which they are concerned. In this regard, there is nothing tosuggest either in the claims themselves or in the body of the specification that a completemolecule of DNAas originally found on chromosome 17 that has been isolated, and thatincludes one or more of the relevant mutations, would be outside the scope of the disputedclaims. This is important because the respondents’ submissions to me suggested that, at leastin the case of DNA, covalent bonds must necessarily be broken as part of the isolationprocess, and that this was in itself something that differentiated naturally occurring DNAfrom isolated DNA in terms of their chemical composition.

73

The respondents pointed to the following evidence of Dr Suthers in support of the propositionthat there will be at least some breaking of the covalent bonds in the sugar phosphatebackbone as a result of the isolation process:

…Now, if you had a gene in the chromosome, and you were going to isolate asequence not by synthesising it but by extracting it, what you would need to achievewould be at least the following–

I’m not saying all the steps?---Sure.

You would need to break the hydrogen bonds between the bases?---Yes.

And you would need to have at least some breaks in the covalent bonds so that youcould take out an extract?---Yes.

Now, when you break the covalent bonds between the sugar and the phosphate sothat you can pull out your extract from the strand, in breaking that bond what you

have isolated is chemically different, isn’t it, to what was in the hole?---It is in termsof, I guess, the molecular weight; the length of the molecule that you’re dealing with.It’s part of the hole. If the part–

you could have avery long strip of DNA which

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contains in the middle of it a coding sequence sufficient to define a particularpolypeptide. If you are able by the means you describe accurately to remove thatcoding region from the longer stretch of DNA, then what you have

removed isshorter, and in that sense, different to what it was before. But in terms of theinformation content, you may not have lost anything.

In fact, in the mid-1990s when you had something–

we will say 100,000 bases, 100kilobases long, you would

normally break it up into much small pieces, wouldn’tyou, and then amplify them?---Absolutely.

And isolate them?---Yes.

74

I do not think Dr Suther’s evidence establishes the broad proposition which it is said tosupport. It is not apparent to me thatevery isolated DNA sequence within the scope of theclaims must have had at least some covalent bonds broken as a result of the isolation process.Nor would I imply any such requirement into the claims merely because, in Dr Suther’sexperience, this is what occurs. To interpret the disputed claims in this way would requireme to impose an impermissible gloss upon the words of the claim.

75

There are two other important points to make concerning the scope of the claims.

76

First, the disputed claims are notto genetic informationper se. They claim tangiblematerials. Much emphasis was placed by the applicants upon the informational character ofDNA as a storehouse of genetic information. But the disputed claims are not to informationas such. They couldnever be infringed by someone who merely reproduced a DNA sequencein written or digitised form.

77

Secondly, because each of the claims is to anisolated

chemical composition, naturallyoccurring DNA and RNA as they exist in cell are not within the scope of any of the disputedclaims and could never, at least not until they had been isolated, result in the infringement ofany such claim.

LEGAL ANALYSIS

Relevant Statutory Provisions

78

The basic requirements of patentability are set out in s

18 of the Act.Section 18(1) relevantlyprovides that:

… an invention is a patentable invention for the purposes of a standard patent if theinvention, so far as claimed in any claim:

(a)

is a manner of manufacture within the meaning of section 6 of the Statute ofMonopolies; and

(b)

when compared with the prior art base as it existed before the priority date of

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20

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that claim:

(i)

is novel; and

(ii)

involves an inventive step; and

(c)

is useful; and

(d)

was not secretly used in the patent area before the priority date of that claim by,or on behalf of, or with the authority of, the patentee or nominated person orthe patentee’s or nominated person's predecessor in title to the invention.

The term “invention” is defined in Schedule 1 of the Act to mean:

…any manner of new manufacture the subject of letters patent and grant of privilegewithin section 6 of the Statute of Monopolies, and includes an alleged invention.

79

Section 6 of the Statute of Monopolies defined the right of the Crown to grant letters patentfor “the sole working or making of any manner of new manufacture within this realm”.However, the expressions “manner of manufacture” and “manner of new manufacture” arenot employed in the Act to literally describe what subject matter may qualify for patentprotection.

Rather, they are expressions that bring into play principles and concepts whichhave been developed over many years to ensure that patent law keeps up with advances inindustry and technology.

80

Section 18(1A) of the Act is concerned with innovation patents. It is not necessary to sets

18(1A) out. As with standard patents, the invention the subject of a claim in an innovationpatent must be a manner of manufacture. Section 18(1A) is followed by s

18(2)-(4). Theyprovide:

(2)

Human beings, and the biological processes for their generation, are notpatentable inventions.

(3)

For the purposes of an innovation patent, plants and animals, and thebiological processes for the generation of plants and animals, are notpatentable inventions.

(4)

Subsection (3)

does not apply if the invention is a microbiological process ora product of such a process.

National Research Development Corporation v Commissioner of Patents

81

The starting point for my consideration of the legal issues that arise is the High Court’sdecision in theNRDC

case. The case was described by Barwick CJ inJoos v Commissionerof Patents

(1972) 126 CLR 611 at 616 as a “watershed” in this area of law, and inGrain Poolof Western Australia v Commonwealth of Australia

(2000) 202 CLR 479 at para

[45] GleesonCJ, Gaudron, McHugh, Gummow, Hayne and Callinan JJ referred to it as a “celebrated

Act was replaced by the 1990 Act, the new Britishlegislation was not followed. There was in s

18(2) an express exclusion frompatentable inventions of human beings and biological processes for their generation.Beyond that the legislature left the matter, in terms of s 18(1)(a), to rest with theconcept of manner of manufacture within the meaning of s

6 of theStatute ofMonopolies, as developed by the Courts, notably in theNRDC

case. This was amatter of deliberate legislative choice.

82

There were three claims in issue in theNRDC

case. All were method claims concerned withthe use of a known chemical composition (“herbicide”) in the eradication or control of weeds.The first claim was directed to the use of the herbicide in the eradication of weeds from

areascontaining leguminous fodder crops of theTrifolium

andMedicago

families, as well as celeryand parsnip. The second and third claims were directed to the use of the herbicide to controlcharlock, creeping thistle and annual nettle weeds in different crop varieties.

83

The examiner raised objections to these claims on the basis that none was directed to anymanner of manufacture. There were two arguments relied upon by the examiner in support ofthat conclusion. The first was that the claims involved

“the mere use of known substances”and the second was that the use of these substances did “not result in any vendible product”.Both arguments relied upon by the examiner were also relied upon by the Commissioner ofPatents (the Commissioner) in the High Court. The first was rejected by the High Court onthe basis that the invention as claimed involved a new and inventive use of a known chemicalcomposition. The second was also rejected by the High Court.

84

The Court (Dixon CJ, Kitto and Windeyer JJ) began its consideration of the argument that amanner of manufacture must result in “vendible product” by remarking that this was “thecentral question in the case”. The Court said (at 268-270):

The central question in the case remains. It is whether the process that is claimed fallswithin the category of inventions to which, by definition, the application of thePatents Act

is confined. The definition, it will be remembered, is exclusive: inventionmeans any manner of new manufacture the subject of letters patent and grant ofprivilege within s. 6 of theStatute of Monopolies. The Commissioner, adoptingcertain judicial pronouncements to which reference will be made, emphasizes theword “manufacture” and contends for an interpretation of it which, though notnarrow, is restricted to vendible products and processes for their production, andexcludes all agricultural and horticultural processes. On the grounds both of thesuggested restriction and of the suggested exclusion he denies that a process forkilling weeds can be within the relevant concept of invention. The appellant,on theother hand, urges upon us a wider view: that there is a “manufacture” such as mightproperly have been the subject of letters patent and grant of privilege under s. 6 of the

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Statute of Monopolies

whenever a process produces, either immediately orultimately, a useful physical result in relation to a material or tangible entity.

Section 6 of theStatute of Monopolies

provides that the declarations of invaliditycontained in the preceding provisions of the Act “shall not extend to any letterspatents and graunts of privelege … hereafter to be made of the sole working ormakinge of any manner of new manufactures within this realme, to the true and firstinventor and inventors of such manufactures, which others at the tyme of makingesuch letters patentsand graunts shall not use, soe as alsoe they be not contrary to thelawe or mischievous to the state by raisinge prices of comodities at home, or hurt oftrade, or generallie inconvenient”:Halsbury's Statutes of England, 2nd ed. vol. 17(1950), p. 619. It

is of the first importance to remember always that thePatents Act

1952-1955 (Cth), like its predecessor thePatents Act 1903

(Cth) and correspondingstatutes of the United Kingdom (see thePatents, Designs and Trade Marks Act

1883,s. 46; thePatents Act

1907, s. 93; and thePatents Act

1949, s. 101), defines the word“invention”, not by direct explication and in the language of its own day, nor yet bycarrying forward the usage of the period in which theStatute of Monopolies

waspassed, but by reference

to the established ambit of s. 6 of that Statute.The inquirywhich the definition demands is an inquiry into the scope of the permissiblesubject matter of letters patent and grants of privilege protected by the section.It is an inquiry not into the meaning of a word so much as into the breadth ofthe concept which the law has developed by its consideration of the text andpurpose of theStatute of Monopolies.

One may remark that although the Statutespoke of the inventor it nowhere spoke of the invention; all that is nowadaysunderstood by the latter word as used in patent law it comprehended in “newmanufactures”.The word “manufacture” finds a place in the present Act, not asa word intended to reduce a question of patentability to a question of verbal

interpretation, but simply as the general title found in theStatute of Monopolies

for the whole category under which all grants of patents which may be made inaccordance with the developed principles of patent law are to be subsumed. It istherefore a mistake, and a mistake likely to lead to an incorrect conclusion, totreat the question whether a given process or product is within the definition asif that question could be restated in the form: “Is this a manner (or kind) ofmanufacture?” It is a mistake which tends to limit one's thinking by reference tothe idea of making tangible goods by hand or by machine, because“manufacture” as a word of everyday speech generally conveys that idea. Theright question is: “Is this a proper subject of letters patent according to theprinciples which have been developed for the application of s. 6 of theStatute ofMonopolies?”

It is a very different question. A perusal of the definitions and quotationsappearing in theOxford English Dictionary

under “manufacture”will show thatthe word has always admitted of applications beyond the limits which a strictobservance of its etymology would suggest, and, as the present Chief Justice saidinMaeder v. Busch

[(1938) 59 CLR 684 at p. 706], a widening conception of thenotion has been a characteristic of the growth of patent law.

(emphasis added)

85

The Court then reviewed various other authorities, mostly decided in the eighteenth andnineteenth centuries, concerning the meaning of s

6 of theStatute of Monopolies

and, inparticular, the expression “manner of manufacture”. This review led the Court to conclude(at

271):

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The truth is that any attempt to state the ambit of s. 6 of theStatute of Monopolies

byprecisely defining “manufacture” is bound to fail. The purpose of s.

6, it must beremembered, was to allow the use of the prerogative to encourage nationaldevelopment in a field which already, in 1623, was seen to be excitinglyunpredictable. To attempt to place upon the idea the fetters of an exact verbalformula couldnever have been sound. It would be unsound to the point of folly toattempt to do so now, when science has made such advances that the concreteapplications of the notion which were familiar in 1623 can be seen to provide onlythe more obvious, not to saythe more primitive, illustrations of the broad sweep ofthe concept.

86

There are three important points that emerge from these passages. First, the Court identifiedthe question that must be addressed for the purpose of determining whether or not subjectmatter is patentable,viz. “[i]s this a proper subject of letters patent according to the principleswhich have been developed for the application of s. 6 of theStatute of Monopolies?”Secondly, this question involves a conceptual inquiry as opposed to a consideration of theetymology of the expression “manner of manufacture”. Thirdly, the concept of manner ofmanufacture has a “broad sweep” intended to encourage developments that are by theirnature often unpredictable.

87

The High Court then turned to some more recent authority including the decision of Morton J(as his Lordship then was) inRe GEC’s Application

(1943) 60 RPC 1. The Court observedthat Morton J’s judgment–

which drew upon the concept of the “vendible product” as acriterion of patentability–

would have “a narrowing effect on the law” if it was literallyapplied. In a key passage of the judgment the Court held (at 277):

Notwithstanding the tendency of these decisions, the view which we think iscorrect in the present case is that the method the subject of the relevant claimshas as its end result an artificial effect falling squarely within the true concept ofwhat must be produced by a process if it is to be held patentable. This view is,we think, required by a sound understanding of the lines along which patent lawhas developed and necessarily must develop in a modern society.

The effectproduced by

the appellant’s method exhibits the two essential qualities upon which“product” and “vendible” seem designed to insist.It is a “product” because itconsists in an artificially created state of affairs, discernible by observing over aperiod the growth of weeds and crops respectively on sown land on which themethod has been put into practice. And the significance of the product iseconomic; for it provides a remarkable advantage, indeed to the lay mind asensational advantage, for one of the most elemental activities by which man hasserved his material needs, the cultivation of the soil for the production of itsfruits.Recognition that the relevance of the process is to this economic activity oldas it is, need not be inhibited by any fear of inconsistency with the claim to noveltywhich the specification plainly makes. The method cannot be classed as a variant ofancient procedures. It is additional to the cultivation. It achieves a separate result, andthe result possesses its own economic utility consisting in an important improvementin the conditions in which the crop is to grow, whereby it is afforded a betteropportunity to flourish

and yield a good harvest.

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(emphasis added)

88

It is apparent from this passage that a product that consists of an artificially created state ofaffairs which has economic significance will constitute a “manner of manufacture”. Inrelation to a process, theproduct is the state of affairs in which an effect may be observed. IntheNRDC

case, the product was the discernible effect achieved by the use of selectiveherbicides which

killed weeds but not particular types of crop to which they might be applied.The economic significance of the methods the subject of the patent in terms of improved cropproduction was virtually self-evident in that case. In the present case, the question ofeconomic significance may be put aside because, as I have previously mentioned, theapplicants accepted that this aspect of the requirements of patentability established byNRDC

was satisfied.

Products of Nature

89

Another argument relied upon by the

Commissioner in theNRDC

case, closely related to thefirst, was that the claims in question were for processes that were “dependent on the operationof natural laws or the natural properties of the materials involved” and that “[t]here is noprocess independent of the discovery itself”. To put this argument in context, it is helpful torefer to what Buckley J said inReynolds v Herbert Smith & Co Ltd

(1903) 20

RPC 123. HisLordship said (at 126):

Discovery adds to the amount of human knowledge, but it does so only by lifting theveil and disclosingsomethingwhich before had been unseen or dimly seen. Inventionalso adds to human knowledge, but not merely by disclosing something. Inventionnecessarily involves also the suggestion of an act to be done, and it must be an actwhich results in a new product, or a new result, or a new process, or a newcombination for producing an old product or an old result.

90

The same point was made by Whitford J inGenentech Inc’s Patent

[1987] RPC 553 wherehis Lordship said (at 566):

It is trite law that you cannot patent a discovery, but if on the basis of that discoveryyou can tell people how it can be usefully employed, then a patentable invention mayresult. This in my view would be the case, even though once youhave

made thediscovery, the way in which it can be usefully employed is obvious enough.

This statement was expressly approved by the House of Lords inKirin-Amgen Inc v HoechstMarion Roussel Ltd

that “… ithas long been established that‘a clear distinction will be drawn between thediscovery of one of nature’s

laws, and of its application to some new and useful purpose

…’”.

92

Returning then to the Commissioner’s argument inNRDC

(that the inventor had made adiscovery but not an invention), the High Court said (at 263-264):

Arguments of this kind may be answeredas Frankfurter J. answered them inFunkBros. Seed Co. v. Kalo Inoculant Co. [(1948) 333 U.S. 127 [92 Law. Ed. 588]]. “Itonly confuses the issue,” the learned Justice said, “to introduce such terms as ‘thework of nature’ and the ‘laws of nature’. For these are vague and malleable termsinfected with too much ambiguity and equivocation. Everything that happens may bedeemed ‘the work of nature’, and any patentable composite exemplifies in itsproperties ‘the laws of nature’. Arguments drawn from such terms

for ascertainingpatentability could fairly be employed to challenge almost any patent”. [(1948) 333U.S., at pp. 134, 135 [92 Law. Ed., at p. 591]]. The truth is that the distinctionbetween discovery and invention is not precise enough to be other thanmisleading inthis area of discussion. There may indeed be a discovery without invention—eitherbecause the discovery is of some piece of abstract information without anysuggestion of a practical application of it to a useful end, or because its applicationlies outside the realm of “manufacture”.

93

Frankfurter J’s criticism of the expressions “the work of nature” and “the laws of nature” didnot involve a rejection of the proposition that “the work of nature” or “products of nature”cannot constitute patentable subject matter. The point made by Frankfurter J, and acceptedby the High Court, was that there are cases in which the use of such expressions will be oflittle assistance because everything in some sense or another involves the work of nature.

was particularly significant given what othermembers of the US Supreme Court had said in that case. The issue inFunk Bros

waswhether a new combination of different strains of bacteria was inherently unpatentable. Thestrains of bacteria were already known, but it was the idea of the inventor to bring themtogether to form a new combination. Douglas J who wrote for the majority on this issue said(at 130):

We do not have presented the question whether the methods of selecting and testingthe non-inhibitive strains are patentable. We have here only product claims. Bonddoes not create a state of inhibition or of non-inhibition in the bacteria. Theirqualities are the work of nature. Those qualities are of course not patentable. Forpatents cannot issue for the discovery of the phenomena of nature. The qualities ofthese bacteria, like the heat of the sun, electricity, or the qualities of metals, are partof the storehouse of knowledge of all men.

(citations omitted)

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95

In 1980, inDiamond v Chakrabarty

447 US 303 (1980) the US Supreme Court distinguishedFunk Bros

and held that a live, human made micro-organism was patentable. The decision inChakrabarty

was considered to be a landmark because it established that a patent could beobtained for something that was living, a characteristic of micro-organisms which many hadassumed rendered such subject matter unpatentable because it was necessarily “thehandiwork of nature” (Funk Bros

at 131).

96

At this point, it is convenient to refer to two authorities relied upon by the applicants. Thefirst isAmerican Cyanamid Companyv Upjohn Company

strain of micro-organism wasnot patentable if it exists in nature. In that case, the House of Lords was concerned with aclaim for a new antibiotic (Porfiromycin) and a method for its production that involvedsubjecting a suitable strain of a particular micro-organism to fermentation. It is apparentfrom the facts of the case that the production of the new antibiotic depended upon finding theright micro-organism to work with. At issue in the appeal was the sufficiency of thedescription of the invention, and whether the patent was invalid because the specificationfailed to indicate how a person seeking to practice the invention might go about obtaining themicro-organism upon which production of the new antibiotic depended. Lord Wilberforce’sspeech contains a clear acknowledgement of how much effort may be required to isolate astrain of a naturally occurring micro-organism. His Lordship said (at 446):

Strains of micro-organisms have been found to be useful in various connections; butvery large numbers of differing varieties are found in nature. The problem for thescientist lies in identifying and isolating the particular strains which, or mutants ofwhich, can be made use of. These may come to light by painstaking or expensiveresearch assisted by good fortune or by pure good fortune: once identified theyrepresent a valuable asset. It may take years of search for other scientists, howevercompetent,

and though provided with full information as to the characteristics of thestrain, to isolate the same strain for themselves, if indeed they can ever succeed indoing so.

Lord Wilberforce went on to observe (at 448) that it was the isolated strain of the micro-organism (a strain of Streptomyces verticillatus) that represented the result of the researcheffort of the inventors but that the strain “being something living, found in nature, cannot bepatented”. The question whether an isolated strain of micro-organism was a manner ofmanufacture (as required by thePatents Act 1949

(UK) which was still in force at the time)

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was not necessary to the decision inDann’s Patent

nor, it appears, was the point the subjectof argument.

98

The applicants also relied upon an observation of Lord Hoffmann in

Kirin-Amgen

which wassaid to support the proposition that a naturally occurring protein (and,a fortiori, naturallyoccurring DNA) was not patentable subject mattereven if it was isolated. His Lordship saidinKirin-Amgen

(para

[132]):

The result isthat I would allow TKT’s appeal and revoke the patent on the groundthat claim 19 is insufficient (s.72(1)(c)) and claim 26 is anticipated (s.72(1)(a)).Standing back from the detail, it is clear that Amgen have got themselves intodifficulties because, having invented a perfectly good and ground-breakingprocess for making EPO and its analogues, they were determined to try topatent the protein itself, notwithstanding that, even when isolated, it was notnew.

(emphasis added)

99

However, it is clear thatLord Hoffmann

did not say that an isolated protein (specifically,erythropoietin, otherwise known as EPO),was inherently non-patentable.The relevantsentence was plainlydirected at the validity of claim 26 whichLord Hoffmannsaid wastosomething thatwas“not new”

and therefore not patentable: see s

1(1)(a) of thePatents Act1977

(UK) (the

UK

Act).

100

Claim 1 inKirin-Amgen

was to a DNA sequence for use in the expression of certainpolypeptides (rEPO) in an eukaryotic host cell.Claim 26 was to “[a] polypeptide product ofthe expression in a eucaryotic host cell of a DNA sequence according to any of claims 1 [andvarious other dependent claims]”:see at 182, para

[15].The reason why claim 26 was held tobe invalid turned on two findings of fact. First, natural occurring EPO (uEPO) hadpreviously been isolated in minute quantities from large quantities of urine collected frompatients suffering from aplastic anaemia. Secondly, rEPO and uEPO have the same chemicalcomposition. It followed that rEPO,even if isolated, could not be new because uEPO hadbeen isolated before rEPO: see generallyKirin-Amgen

at paras

[5], [86]-[87], [96]-[101].

101

Whether or not a composition of matter (including a micro-organism) is a “manner ofmanufacture” must be decided

in accordance with the principles set out in theNRDC

case. Itfollows (leaving aside any relevant statutory exception) that a composition of matter mayconstitute patentable subject matter if it consists of an artificial state of affairs, that has somediscernible effect, and that is of utility in a field of economic endeavour.

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102

It goes without saying that the relevant state of affairs must be the result of some humanintervention. After all, it is the element of human intervention that allows one to bothcharacterise the relevant state of affairs as being artificial and to identify one or moreinventors who, one way or another, must have brought such a state of affairs into existence inthe first place. The real problem lies in knowing, or rather not knowing, what degree ofhuman intervention is necessary before it can be concluded that the requisite artificial state ofaffairs exists. It is an especially difficult problem in the present case, not so much becausethe authorities provide no clear solution to it, but because the problem has an almostmetaphysical dimension to it.

103

There are two further points to be made concerningNRDC.

First, it is important to note thatNRDC

does not require the Court to ask whether a composition of matter is a “product ofnature” for the purpose of deciding whether or not it constitutes patentable subject matter.NRDC

recognises that it may be unhelpful to approach the problem in this way.

I think this isespecially so in the field of biotechnology in which micro-organisms play a critical role in thedevelopment, manufacture and use of diagnostic and therapeutic products and techniques.And second,NRDC

does not require the Court to ask whether a micro-organism is “markedlydifferent” to something that already exists in nature for the purpose of deciding whether itconstitutes patentable subject matter (cf.Chakrabarty

at 310).

Isolated nucleic acid

104

In the context of biological material,an artificial state of affairs may manifest itself indifferent ways. The physical properties of the naturally occurring material may have changedas a result of it having been isolated. But even if the physical properties of the material havenot changed, the removal of the material from its natural environment and its separation fromother cellular components may still give rise to what might reasonably be described as anartificial state of affairs.

105

In my opinion the patentability of the isolated nucleic acids referred to in the disputed claimsdoes not turn upon what changes have been made to the chemical composition of suchsubstances as a result of them having been isolated. In particular, the question of whetherthese substances constitute patentable subject matter does not depend upon the type ofchemical bond that may have been broken in the process of isolating them. It is inevitablethat some bonds will be broken in the course of isolating nucleic acids, but it is not apparentfrom the evidence that these will necessarily include covalent bonds. As I have already

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explained, the disputed claims do not require that the isolated nucleic acids they describediffer from those found in the cell in this or any other respect so far as their chemicalcomposition is concerned.

106

Accordingly, the issue in this case turns upon whether an isolated nucleic acid, which may beassumed to have precisely the same chemical composition and structure as that found in thecells of some human beings, constitutes an artificial state of affairs in the sense those wordsshould be understood in the present context. There are three considerations which lead me tothink that it does.

107

First, in explaining the concept of manner of manufacture as one involving the creation ofanartificial state of affairs, it is apparent that the High Court inNRDC

was deliberate in its useof very expansive language. Not only did the High Court emphasise the “broad sweep” ofthe concept involved, it also made clear that metaphorical analysis

may not be helpful indetermining whether or notsomething

constitutes patentable subject matter.

108

Secondly, in the absence of human intervention, naturally occurring nucleic acid does notexist outside the cell, and “isolated” nucleic acid does not exist inside the cell. Isolatednucleic acid is the product of human intervention involving the extraction and purification ofthe nucleic acid found in the cell. Extraction of nucleic acid requires human intervention thatnecessarily results in the ruptureof the cell membrane and the physical destruction of the cellitself. And purification of the extracted nucleic acid requires human intervention that resultsin the removal of other materials which were also originally present in the cell. It is onlyafter both these steps are performed that the extracted and purified product may be properlydescribed as “isolated” in the sense that word is used in the disputed claims.

109

Thirdly, asDann’s Patent

demonstrates, the isolation of a particular micro-organism mayrequire immense research and intellectual effort. In that case, it was only as a result of anintensive research effort that the isolated micro-organism in question could be made availablefor use in the manufacture of the new antibiotic. It was fortuitous for the patentee that it wasits employees who were first to isolate the new micro-organism and first to deploy it in themanufacture of the new drug. That will not always be so. It would lead to very odd results ifa person whose skill and effort culminated in the isolation of a micro-organism (a

fortiori, anisolated DNA sequence) could not be independently rewarded by the grant of a patentbecause the isolated micro-organism, no matter how practically useful or economicallysignificant, was held to be inherently non-patentable. In my view it would be a mistake, and

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inconsistent with the purposes of the Act, not to give full effect in such situations to the broadlanguage used by the High Court inNRDC.

110

The applicants argued that what the High Court said inNRDC

should not be taken tooliterally. In support of this argument they referred to the observation of Lord Walker inKirin-Amgen[2005] RPC 169 where his Lordship said (at para

[138]):

There is always a danger that any judicial summary of principle may, preciselybecause it is concise, practical and repeatedly cited, take on a life of its own, as if itwere a statutory text with its own problems of construction to be resolved …

At the most general level, one cannot but agree with this statement. Here, however, I am notconcerned with the construction of statutory text. The present case is to be resolved not byreference to statutory language in any conventional sense, but by the application of principlesand concepts developed by the Courts as explained inNRDC

and other relevant authorities.The High Court’s decision inNRDC

is a definitive statement on the question of whatconstitutes patentable subject matter, and unless some good reason existsto distinguish it, itshould be applied in a manner that gives effect to the broad language that was used.

RECENT AMENDMENTS AND THEIR HISTORY

111

It is useful to look to the legislative history of some recent amendments to the Act for thepurpose of determining whether the conclusion I have come to might for some reason be seento be inconsistent with Parliament’s intentions.

112

It is important to observe, even though it may go without saying, that the Act does notinclude any provision that specifically precludes the grant of a patent for an isolated DNA orRNA sequence. In particular, s

18(2) of the Act provides only that “human beings, andbiological processes for their generation” are not patentable. A proposal that thePatents Bill1990

(Cth) be amended

to include a similar provision that would have treated DNA and RNAin the same way was not adopted. The inference to be drawn is that it was not the intentionof Parliament at the time the Act was passed to deal with the issue of “gene patenting” bywayof express statutory exclusion along the lines of s

18(2), but to leave it to the Courts toapply the law as settled in theNRDC

case and other relevant authorities.

Early decisions of the Australian Patent Office on the patentability of isolated DNAsequences

113

Until now, there have been no judicial decisions in this country which have considered thepatentability of isolated DNA or RNA sequences. However, there have been a number of

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decisions issued by the Australian Patent Office which have referred tothe point. The firstreported decision of the Australian Patent Office allowing a claim to isolated DNA was madein the context of an opposition proceeding in the matter ofKirin-Amgen Inc v Board ofRegents of University of Washington

(1995) 33 IPR 557.

In that matter, the DeputyCommissioner of Patents (Mr D Herald) noted that no objection had been taken by theopponent to various claims in the opposed patent application on the ground that their subjectmatter involved the “mere discovery” of the DNA sequence encoding erythropoiten.Nevertheless, Mr

Herald, having raised the issue himself, said (at 569):

The present invention fundamentally relies upon the discovery of the DNA sequenceencoding erythropoietin. In my view a claim directed to naturally occurring DNAcharacterised by specifying the DNA coding for a portion of that molecule wouldlikely be claiming no more than a discovery per se and not be a manner ofmanufacture.

The present specification contains claims to DNA sequences, in two categories:

•

Claims 14, 17, 18, and 55, which claim a“purified and isolated”

sequencelimited to that specified in tables V or VI, or limited to being“essentially”

thesequence encoding erythropoietin. These claims are directed to a molecule whichis a fragment of

the full chromosome. They do not claim the naturally occurringchromosome, or any other naturally occurring entity. By being directed to apurified and isolated DNA sequence they claim“an artificially created state ofaffairs’’.

•

Claim 33 claims:

A DNA sequence coding for a polypeptide analogue of naturally-occurring erythropoietin.

and claim 34

claims:

A DNA sequence coding for …

specifying human erythropoietin with a range of substitutions ordeletions.

Both claims include within their scope a full length chromosomecontaining the relevant sequence, because they are not restricted toa“purified and isolated”

sequence. However, both claims aredirected to molecules which have been deliberately changed fromthe naturally occurring form-

ie they are directed to artificiallycreated states of affairs.

I also observe that an objection of manner of manufacture might arise if the claimswere directed to a mere chemical curiosity; but that is plainly not the case with thisinvention.

Accordingly, I am satisfied that an objection of manner of manufacture does notapply to any of the claims.

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114

Mr Herald’s reasoning and conclusion are succinctly expressed but they are consistent withthe view I have reached in the present matter. What is more important for present purposes,is that this decision reflected what is now the long standing practice of the Australian PatentOffice in relation to claims to isolated DNA sequences so far as the requirements ofs

18(1)(a) of the Act are concerned.

The Australian Law Reform Commission’s Report into Gene Patenting

115

The patentability of gene sequences has received close attention from the Australian LawReform Commission (ALRC) after it received a reference in December 2002 from the thenAttorney General. The ALRC provided its detailed report on the topic to the AttorneyGeneral more than 13 years ago.

116

In its report dated 29 June 2004 entitledGenes and Ingenuity: Gene Patenting and HumanHealth

(ALRC 99, 2004) (the ALRCReport), the ALRC recognised that legitimateconcerns could be raised in relation to patents for isolated biological materials that occur innature. But on the basis that there was a settled practice of granting patents in respect of suchmaterials the ALRC didnot favour any change to the law aimed at curtailing the practice.The ALRC said (at paras

6.51-6.53):

6.51

It is clear that theprocesses

for identifying, isolating and purifying naturallyoccurring materials, including biological material such as genetic sequences,should be patentable when those processes satisfy the other requirements ofpatentability

–

namely, when they are novel, inventive, useful and fullydisclosed. However, legitimate concerns have been raised about the patentingof biologicalmaterials

that occur in nature, but have been isolated andpurified by humans. Isolated biological materials may, in some cases,replicate exactly the composition and characteristics of material that occursin nature. Although one cannot deny the legitimacy of patenting processes forisolating and purifying naturally occurring materials, or the legitimacy ofpatenting new chemical substances that are the product of human ingenuity,there are attractive arguments for the view that such materials should nothave

been treated as patentable subject matter.

6.52

However, the time for taking this approach to the patenting of products andmaterials has long since passed. For decades, naturally occurring chemicalshave been regarded by patent offices in many jurisdictions as patentablesubject matter, when they are isolated and purified. This principle has beenapplied by analogy to biological materials, including genetic sequences, onthe basis that they are ‘merely’ complex organic compounds. Thisdevelopment was certainly not foreseen when the modern patent system wasestablished, and a different approach might have been available when theissue first arose for consideration.

6.53

Nonetheless, the ALRC considers that a new approach to the patentability ofgenetic materials is not warranted at this stage in the development of thepatent system, for the following reasons:

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•

It would represent a significant and undesirable departure fromaccepted international practice with respect to genetic inventions, andmay adversely

affect investment in the Australian biotechnologyindustry.

•

It may fail to deliver the anticipated benefits because many pure andisolated genetic sequences do not exist in exactly the same form innature–for example, patented sequences may not containthe intronsthat are found in the naturally occurring material.

•

Claims to genetic materials in their natural form (that is,in situ) do notconstitute patentable subject matter.

•

Arguments that genetic materials are not patentable inventions do notalways take adequate account of the fact that–

in addition to thethreshold requirement of ‘patentable subject matter’–

a number ofstatutory requirements must be satisfied for patent protection to beobtained. In particular, patent protection cannot beconferred overgenetic materials unless a use for such materials has been identifiedand fully disclosed.

•

It would be difficult, on any rational basis, to confine reform to geneticmaterials and technologies, yet the extension of the reform to otherfields–

where the patenting of pure and isolated chemicals that occurin nature is uncontroversial–

may have unknown consequences.

117

The ALRC Report went on to suggest that the test for patentable subject matter may warrantreform. It recommended (at para

6.58) that the responsible Minister initiate an independentreview of the appropriateness and adequacy of the “manner of manufacture” test. In 2008 theMinister for Innovation, Science and Research (Senator Kim Carr) initiated such a reviewwhich resulted in

the Advisory Council on Intellectual Property releasing a report entitledPatentable Subject Matter(December 2010) (the ACIP Report). Around the same time thatthe ACIP Report was released, another report prepared by the Senate Community AffairsReferences Committee entitledGene Patents

(November 2010) (the SCA

Report) was alsotabled in the Senate.

118

Also inlate 2010 thePatent Amendment (Human Genes and Biological Materials) Bill 2010(Cth) was introduced into the Senate as a Private Members’ Bill.

The Bill sought to excludepatents of “biological materials including their components and derivatives, whether isolatedor purified or not and however made, which are identical or substantially identical to suchmaterials as they exist in nature.”

The term “biological materials”

wasdefinedto includeDNA

andRNA.

The Bill was referred to the Legal and Constitutional Affairs LegislationCommittee(LCAC)for inquiry anditsreportwastabledin the Senateon 21

September2011.

In its report the LCACrecommended(by majority)that the Senate not pass the Bill

which eventually lapsed.

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119

The Australian Government issued a response to the SCA Report in November 2011 (theAustralian Government Response). In fact the Australian Government Responseresponded not merely to the SCA Report but also to the ACIP Report and, most relevantly,the ALRC Report. The Australian Government Response specifically accepted the ALRC’srecommendation that the Actnot

be amended to exclude (inter alia) genetic materials andtechnologies from patentable subject matter (see the Australian Government Response atp

17). At the same time it accepted a range of recommendations calling for amendments tothe Act that would impose stricter tests in relation to the other patentability requirementsreferred to in s

18(1)(b)(i) (novelty), s

18(1)(b)(ii) (inventive step) and s

18(1)(c)(usefulness). The Australian Government Response also accepted a number of othersignificant recommendations including the recommendation calling for the introduction of anew “experimental use” defence.

Intellectual Property Laws Amendment (Raising the Bar) Act 2012

(Cth)

120

Many of the recommendations that were accepted in the Australian Government Responsewere implemented by theIntellectual PropertyLaws Amendment (Raising the Bar) Act 2012

(Cth) (the Amendment Act). In particular, the Amendment Act introduced into the Act anew experimental use defence, which took effect on 16 April 2012 (see now s

119C of theAct) and a new definition of “useful” which will take effect from 15 April 2013 (which willbe s

7A of the Act).

121

Section 119C is significant in the present context. This is because one of the main argumentsthat has been advanced against the patentability of isolated DNA sequences (as well asotherbiological materials) is the impact that patents for such materials may have on future researchinto previously undiscovered genetic mutations and research and the development of newdiagnostic and therapeutic technologies that may only take place using patented biologicalmaterials.

122

The introduction of s

7A is also significant in the present context. Section

7A will make itmore difficult for patent applicants to obtain patent protection for expressed sequence tags(ESTs). ESTs are short nucleotide sequences that represent a fragment of a cDNA “clone”that have proven especially controversial in circumstances where their principal use is as aresearch or experimental tool. (For a detailed discussion of the controversy surroundingESTs, includingreferences to the ALRC’s consideration of them, see Dr

Matthew Rimmer,

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The New Conquistadors: Patent Law and Expressed Sequence Tags

(2005) 16 J. L. Inf. &Sci. 10.)

123

Of course, the history to the Amendment Act, including the Australian Government Responseto the ALRC Report, does not bear directly on the proper scope of the “manner ofmanufacture” requirement. This is because the question whether isolated nucleic acid iswithin the broad sweep of the concept of manner of manufacture is to be decided inaccordance with the principles developed for that purpose, rather than the legal principles orstatutory provisions that are concerned with the proper interpretation of a statute. Even so,these are not matters that can be completely ignored. I think it isimportant to recognise thatthe recent and imminent changes to the Act address at least some of the problems thatopponents of the Australian Patent Office’s long standing practice have previously identified.

THE PATENT LAWS OF THE EUROPEAN UNION AND THEUNITED STATES

124

Both parties referred me to the legal position in the European Union (EU) including,

inparticular, the United Kingdom (UK) and the United States (US). I will briefly summarisethe legal position in these jurisdictions.

The European Union

125

On 12 May 1998 the European Parliament approved the Directive on the Legal Protection ofBiotechnological Inventions (the BPD). The BPD came into force on 6

July 1998 asDirective 98/44/EC. The EU States were given until July 2000 to implement the directivethough not all did so. However, the BPD has now been implemented by all current membersof the EU. See generally Philip

An invention shall not be considered unpatentable solely on the ground that itconcerns

–

(a)

aproduct consisting of or containingbiological material; or

(b)

a process by which biological material is produced, processed or used.

…

5.

An element isolated from the human body or otherwise produced by means ofa technical process, including the sequence or partial sequence of a gene,may constitute a patentable invention, even if the structure of that element isidentical to that of a natural element.

128

It is clear from these provisions that in the UK, as in many other parts of Europe, isolatedDNA and isolated RNA may be patentable even though they are identical in their chemicalcomposition to DNA and RNA found in the cell.

The United States

129

The parties made detailed submissions in relation to the decision of the United States Courtof Appeals for the Federal Circuit in the matter ofThe Association for Molecular Pathology

& Ors v United States Patent and Trademark Office

and Myriad Genetics Inc

653 F3d 1329(2011). However, after the present case was argued, theMyriad

case was re-argued beforethe Court of Appeals for the Federal Circuit which delivered it most recent decision in thematter on 16

August 2012 (The Association for Molecular Pathology

& Ors v United StatesPatent and Trademark Office

and Myriad Genetics Inc

689 F3d 1303 (2012)). The re-argument occurred as a result of adecision of the US Supreme Court vacating the earlierMyriad

decision and remanding the case for further argument in light of the US SupremeCourt’s own decision inMayoCollaborativeServices v PrometheusLaboratoriesInc

132SCt 1289 (2012).

130

TheMyriad

litigation concerned a US patent that is closely related to the Patent in issue inthe present case. It involved a challenge by the plaintiffs to the validity of the firstrespondent’s (ie. Myriad Genetics Inc’s) US patent including claims to isolated DNA(claims1 and 2) in these terms:

1.

An isolated DNA coding for a BRCA1 polypeptide, said polypeptide havingthe amino acid sequence set forth in SEQ ID No:2.

2.

The isolated DNA of claim 1, wherein said DNA has the nucleotide sequenceset forth in SEQ ID NO:1.

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131

By majority the Court of Appeals for the Federal Circuit upheld the validity of these claims intheMyriad

appeal. One member of the majority (Lourie J) placed emphasis upon the smallersize of isolated DNA compared to the size of a naturally occurring DNA molecule, and thatan isolated DNA molecule was different to a naturally occurring DNA molecule as a result ofhaving had covalent bonds in its backbone chemically severed (at 1328).

132

The other member of the majority (Moore J) also upheld the validity of the claims to isolatedDNA sequences. However, Judge Moore placed much greater emphasis upon the long-standing practice and guidelines of the US Patent Office in granting patents for isolated DNAmolecules that have the same sequence as a naturally

occurring gene on the basis that theDNA molecule does not occur in nature in isolated form. Her Honour said that this practicehad given rise to “exceedingly valuable property rights” and “settled expectations of thebiotechnology industry”. Her Honour

appeal (Bryson J) delivered a forceful dissent inrelation to the patentability of isolated DNA (but not cDNA). Judge Bryson was notpersuaded by either of the different approaches favoured by the majority. As to the first ofthese, his Honour said (at 1355):

Neither isolation of the naturally occurring material nor the resulting breaking ofcovalent bonds makes the claimed molecules patentable. We have previously statedthat“isolation of interesting compounds is a mainstay of the chemist’s art,”

and that“[i]f it is known how to perform such an isolation doing so‘is likely the product notof innovation but of ordinary skill and common sense.’”Similarly, the structuralchanges ancillary to theisolation of the gene do not render these claims patentable.The cleaving of covalent bonds incident to isolation is itself not inventive, and thefact that the cleaved molecules have terminal groups that differ from the naturallyoccurring nucleotide sequences does nothing to add any inventive character to theclaimed molecules. The functional portion of the composition–the nucleotidesequence–remains identical to that of the naturally occurring gene.

(citations omitted)

As to the approach adopted by Judge

Moore, his Honour gave several reasons which lead himto conclude that the US Patent Office’s long standing practice and guidelines should not begiven significant weight (at 1357-1358).

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134

On 30 November 2012, the US Supreme Court announced that it would hear an appeal in theMyriad

case. The US law in relation to the patentability is therefore not likely to be settleduntil the Supreme Court reaches it own decision on the issue.

135

In any event, it seems to me that theMyriad

decision does not provide any direct assistance toeither side in the present case. I say this for two reasons. First, the law in Australia isdifferent. I must apply the law as explained inNRDC. It must also be recognised, especiallyas theMyriad

case heads to the US Supreme Court, that the constitutional setting in whichpatent legislation operates in the US is quite different to that in which patent legislationoperates in this country:Grain Pool of Western Australia v Commonwealth of Australia

(2000) 202 CLR 479 at paras

[28]-[32]. Secondly, the evidence in theMyriad

case was notthe same as the evidence in the present cast. And at least in relation to the matter of covalentbonds, I have taken a different view of the facts to that taken by Judge Lourie.

CONCLUSION

136

There is no doubt that naturally occurring DNA and RNA as they exist inside the cells of thehuman body cannot be the subject of a valid patent. However, the disputed claims do notcover naturally occurring DNA and RNA as they exist inside such cells. The disputed claimsextend only to naturally occurring DNA and RNA which have been extracted from cellsobtained from the human body and purged of other biological materials with which they wereassociated.

137

The applicants contended that each of the disputed claims was invalid on the sole ground thatit was not a claim to a manner of manufacture and therefore did not comply with therequirements of s

18(1)(a) of the Act. That contention should be rejected for

the reasonspreviously given. In my opinion each of the claims is to a manner of manufacture as thatexpression should now be understood. My reasons have nothing to say about the possibleinvalidity of the disputed claims on any other ground.

138

In the result, the amended application will be dismissed with costs. I will stay the costs orderunder such time as any appeal that may be brought has been heard and determined.